Orphan Drugs: FDA September 2014 Approvals
The chart below identifies Orphan Drugs receiving FDA September 2014 approval as of 09/30/14 in ascending “Approval Date” order.
FDA September 2014 Orphan Products Receiving Approval
|#||Generic Name/Approval Date||Sponsor Company||Indication|
|1||Pembrolizumab (Keytruda)/ 09.04||Merck||Unresectable/metastatic melanoma & disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor|
|2||Adalimumab (Humira)/ 09.23||AbbVie||Patients > 6 years of age with moderately to severely active Crohn’s disease who had an inadequate response to corticosteroids/ immunomodulators|
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